Post Market Surveillance (PMS) Report

The PMS system plays a pivotal role in identifying potential issues related to design, manufacturing, or clinical use. By continuously monitoring device performance throughout its entire lifecycle, manufacturers can ensure:

• Early detection of risks or failures
   
• Up-to-date risk-benefit evaluations
   
• Prompt implementation of necessary improvements
   

Manufacturers are also expected to monitor similar devices on the market, including those from competitors, to maintain a comprehensive view of safety trends and performance benchmarks.

Save time and ensure compliance with our ready-to-use Microsoft Word PMS Report Template, crafted by regulatory experts. These templates meet the standards of EN ISO 13485:2016 (Section 8.2.1) and align with Meddev NB-MED/2.12/Rec.1 guidelines, making them ideal for demonstrating regulatory compliance during audits or reviews.

Even for Class I medical devices—including subclasses Is (sterile), Im (measuring), and Ir (reusable surgical instruments)—manufacturers are required to develop and maintain a Post-Market Surveillance (PMS) Report. This report must provide a concise summary of findings, conclusions, and actions taken based on post-market data.

The PMS report must:

• Summarize relevant findings from ongoing surveillance
   
• Justify corrective and preventive measures taken
   
• Be updated regularly in line with new data and insights

At RAPS, we offer expert resources to help Class I device manufacturers stay compliant and proactive. Our solutions are designed to:

• Guide manufacturers in creating and implementing a compliant PMS Plan
   
• Support the full PMS process, from data collection to reporting
   
• Provide a structured PMS procedure and customizable PMS Report template
   
• Identify Post-Market Clinical Follow-up (PMCF) needs emerging from PMS data
   
• Help interpret PMS findings to inform ongoing device safety and performance
   

Manufacturers are advised to assemble a cross-functional PMS team, involving representatives from regulatory, quality, clinical, and technical departments. This team is responsible for coordinating surveillance activities and ensuring compliance with MDR Article 85 requirements for Class I devices.

Collaborating with regulatory experts and consultants—like those at RAPS—can also enhance your PMS strategy. We help you:

• Define your target patient or user group
   
• Predict and mitigate risks more effectively
   
• Design responsive monitoring programs for new technologies
   

Early identification of issues through a proactive PMS approach ensures not only regulatory compliance, but also improves patient safety and builds market confidence in your product.

An effective Post-Market Surveillance (PMS) Report goes beyond regulatory compliance—it forms the foundation of a manufacturer’s ongoing safety, performance, and risk evaluation for medical devices.

When developing a PMS Report, manufacturers must evaluate:

• The technology of the device
   
• Its position in the market
   
• Comparable devices already in use
   
• The target patient population
   
• The manufacturer’s capabilities to monitor and act on field data
   

For newer technologies or emerging manufacturers, the complexity of real-world device use and patient variability can pose challenges—making a robust PMS strategy even more essential.

Aligned with EU MDR 2017/745, particularly Article 2(60), a comprehensive PMS Report should include:

• Analysis of Current Market Data: For low-risk devices with long usage history, real-world market data may suffice to meet clinical evaluation needs.
   
• Clinical Data Review: Reference to peer-reviewed literature supporting the device’s safety and performance.
   
• Proactive Risk Detection: Systems for identifying unanticipated hazards post-launch through increased monitoring and trend analysis.
   
• Post-Market Clinical Follow-Up (PMCF): Where needed, implementation of a PMCF Plan per Annex XIV Part B, or justification if PMCF is not applicable.
   
• Performance Evaluation Methodologies: Clearly defined methods to reliably evaluate device performance and benchmark against similar devices.
   
• Risk-Benefit Monitoring: Use of measurable indicators and threshold values to continuously assess risk-benefit ratios, as outlined in Annex I Section 3.
   
• Trend Reporting Protocols: Mechanisms to identify statistically significant changes in incident trends in line with Article 88.
   
• Communication Processes: Established protocols for notifying competent authorities, notified bodies, distributors, and end users as needed.
   
• Regulatory Compliance Procedures: Documentation of compliance with Articles 83, 84, and 86, detailing responsibilities, timing, and reporting channels.
   
• Corrective and Preventive Action (CAPA): Defined procedures for initiating appropriate actions in response to findings.
   
• Device Traceability: Tools to trace devices that require recall, replacement, or repair.